(February 2010) What are the “next generation” contraceptives? Several innovative contraceptive methods are expected to enter the market within five years, and more are under development. What are they and who is likely to use them? How might new methods help reduce the unmet need for contraception of an estimated 200 million women worldwide?

During a PRB Discuss Online, Judy Manning and Mihira Karra of USAID and Karin Ringheim of PRB, answered participants’ questions about promising new contraceptive methods and the factors that keep many women from using family planning even when they do not want to become pregnant.

Feb. 25, 2010 1 PM EST

Transcript of Questions and Answers

Andrew Cummings: A new contraceptive that is 100% effective in stopping the transmission of all diseases including HIV/AIDS and 100% effective at preventing pregnancy would be great. But how effective will it be if no one uses it? Are we going to start forcing next generation contraception on people because we know what is best for them? Judy M. Manning: All USAID-supported family planning programs are built on the foundation of voluntary use and informed choice. Education is the key: when women and men, youth and adult, understand the consequences of too many births, too closely spaced, and starting at a very young age, they usually seek some sort of way to plan and ultimately limit their family size. When you add a second dimension of protecting oneself against other reproductive health concerns, such as HIV, the potential for use increases even more so. This is one reason why USAID is investing in the development of multipurpose prevention technologies. But again, education is key to expanding use of all prevention methods.

Mary Lyn Gaffield: Will the ‘next generation’ contraceptives benefit women with pre-existing medical conditions ? Will studies be conducted among women with various conditions and characteristics so that they can benefit as well ? Mihira Karra: The major focus of USAID’s work is on getting existing methods more accessible and increased use of these methods. any biomedical work we currently do is focused on reducing side effects and improving counseling about side effects. We are not currently working on the above issue. However,I think NIH is working on this issue but I am not in a position to provide details of their work.

Dr. Anima Sharma: Dear Panelists, It is a very thought-provoking topic, you have chosen for the discussion. You know, I am an Indian Anthropologist. I have done extensive field work in urban (slums and other income groups), rural (agriculturists and labourers) and tribal areas on various issues including HIV/AIDS, RTIs/STIs. I have found that even after many initiative and slogans started by GoI, the issues like birth control and unsafe sex still have not been able to acheive the targetted results. One of the reason being heterogeniety of population supported by various sociocultural norms. I think that we need to create awareness and make the common people realize the gravity of the situation (in terms of demographic trends) which may become the part of a Contraceptive ‘Strategy’. I am using the word strategy purposefully here. According to me it would be a composite programme with ulti-pronged intervention, only then we can make a dent, especially in the developing countries. In this strategy the people of the lower wrung of the society need more attention. What do you say? Am I thinking in the right direction. Or may be it is just a point of view. Best, Mihira Karra: Thank you Dr. Sharma for your thoughtful comment. There are many reasons that the Indian Family Planning Program has not achieved as much as it could possibly have over the last several decades, in spite of being the first major public sector program. One of the major reasons is possibly a lack of choice of methods and a narrow focus on sterilization, and lack of a whole program approach that we now know is required for success. To be more specific, successful FP programs have many elements. Some of these include: a wide choice of methods for both spacing and limiting; appropriate counseling; mass media and awareness raising; appropriate systems for training, monitoring, supervision, etc.;involving men and women (and not just women alone); having programs for young people, rural populations, urban poor, etc.; improved comprehensive access which includes removal of psychosocial and other barriers for women and men to access services-these are all part of a comprehensive approach to FP and other health services. In addition, political commitment and a good mix of public and private sector approaches seem to be necessary for success. The demographic argument works well at the macro policy level, while at the micro individual level, well planned FP/RH programs try to directly address women’s and men’s needs. In India, depending on the State, there is a huge unmet need for contraception, both for spacing and limiting. In addition, there is limited choice of spacing methods and limited access to services for some key sections of the population. Also, majority of people in India seem to get their health services from the private sector, while the majority of FP services are in the public sector and of questionable quality. These are all factors to consider. In spite of these drawbacks, some States have made remarkable strides in recent years, and the most recent NFHS, I think, shows that about 10 States/union territories have reached replacement level fertilty and several others are close. The major advantage for donors like USAID to work in india, is that unlike a lot of developing countries, India is pretty self sufficinet financially and a very small percent of its overall budget comes from outside sources. So, in theory, any technical advances and new approaches could be introduced in a sustainable way in India and USAID has had some success in this regard in UP, Uttarkhand and Jharkhand (the India USAID Mission will have more information about the details). The donors in india therefore focus on technical support. Of course, moving anything through the Indian bureaucracy has its own challenges!!!

Tolu Dawodu: 1) Instead of research focusing on advancing these new generation contraceptives shouldn’t it focus on improving the already existing ones, like improving the efficiency of condoms, i.e making them less prone to breaking, and reducing the side effects of oral pills? It seems to me that women in developing countries will be less likely to use surgical procedures like the under skin patch or injectables. 2) Your paper raises the issue of the under-utilization of existing birth control methods. What steps are being taken, if any on promoting the use of already existing methods. 3) Can the 200 million women with unmet needs be categorized into developing and underdeveloped nations, or into educated and uneducated categories in order to target specifically the reason for their unmet needs. In increasing accessibility, are instructions being printed in local languages, since most of these contraceptives are made in English speaking countries? Mihira Karra: The majority of USAID’s portfolio is on increasing the use of existing contraceptives, through improved counseling, improved approaches to reaching women and men from all walks of life – rural and urban, with an added focus on reaching the lower economic quintiles and youth. We have a comprehensive operations and program research portfolio to improve access and quality of services and information and develop innovative approaches to reach the underserved with a larger choice of existing methods, for both spacing and limiting. At the same time, we are focusing some attention on improving existing methods or developing new ones that have significant marginal advantages and fill some critical gaps in our current repertoire of methods. Some examples include – the development, testing and rapidly increasing use of two scientific, simple and highly effective fertility awareness based methods (the Standard Days Method, SDM, and The Lactational Amenorrhea Method, LAM please refer to irh.org for more information), a one-size fits most diaphragm (the PATH SILCS) and a 12 month hormonal ring that can be inserted and removed by women and is expected to fill an important gap in our choice of methods. So our research program at USAID is a balanced approach to improving access, quality and use of contraception.

nizigama: ARE NEWER METHODS [free] OF SIDE EFFECTS? Mihira Karra: One of the purposes of developing new methods or improving existing ones is to decrease side effects to increase acceptability and continuation. The three newer methods that have no side effects and are highly effective (over 95% in perfect use and over 89% in typical use) are the fertiltiy awareness based modern methods, the Standard Days Method (SDM),the Lactational Amenorrhea Method (LAM),and the Twoday method (TDM). Please refer to irh.org for more information on these methods. However, it is important to note that contraceptive counseling with clients should include a discussion of possible side-effects and ways to ameliorate these effects. Unfortunately,counseling tends to be one of the weaker links in most systems with women either not being aware that the majority of side effects of hormonoal contraceptives and IUDs are not harmful and also what to do when experiencing them. Judy M. Manning: One of USAID’s goals in improving existing methods and developing new methods is to reduce side effects, which are often the primary reason for discontinuation. Besides refining the type of hormone used to reduce related side effects (such as intermenstrual bleeding), we are also working on better counseling during method provision and follow-up to ensure that users are fully informed as to what to expect and how to manage any side effects, especially during the first few months of use (when the side effects of a hormonal method tend to be most apparent). Thus, dealing with side effects is a two-pronged approach: improve the active compound to reduce side effects, and improve client counseling re expectations of possible side effects.

Emeka Nwosu, Nigeria: Are contraceptives not leading to an increase in STD’S and HIV? Mihira Karra: Contraceptives do not lead to an increase in STDs and HIV. STDs and HIV are a direct result of unprotected intercourse with an infected partner or an exchange of infected bodily fluids through some other means such as blood transfusions or infected needles. The means to protect oneself from these infections is decreasing the number of partners, using condoms consistently and correctly, using clean needles and testing blood in blood banks. Contraceptives do not increase these infections. In fact, two contraceptives actually provide excellent protection for women and men against these infections – male and female condoms, when used correctly and consistently. If the fear is that contraceptives make youth more promiscuous, there is no evidence for this and there is evidence that providing comprehensive information and services to women, men and youth, about all ways to protect themselves, including abstinence, actually is beneficial in improving behaviors and reproductive health outcomes. Judy M. Manning: If you mean USE of contraceptives, certainly not—in fact, the barrier methods available (male and female condoms, diaphragms, cervical caps) actually provide the additional benefit of reducing STI transmission, along with preventing pregnancy. Use of contraceptives has been shown to increase user perceptions of other reproductive health concerns, such as STIs, and their own relative risk. And amongst HIV+ women, use of contraceptives has been demonstrated to be THE most effective way to prevent mother to child transmission of HIV.

shakila: intoduction of newer methods—how [will it] … influence the quality of care and … unmet need for limiting births [?] Judy M. Manning: Hopefully the introduction of new methods will help to increase the method mix, and thus enable women to find a contraceptive method that most suits them. Meeting women’s contraceptive needs at different points in their reproductive lives will do much to increase quality of care around family planning. And anything we can do to increase contraceptive use will help meet unmet need and reduce unwanted pregnancy. Mihira Karra: Research has shown that every time a new method is added to a program it increases CPR. This also means methods that are new to a particular program and not just newly developed methods. For example, if a program currently has only condoms and pills, then adding injectables alone can increase CPR, and adding other short and long term methods will increase it further, etc. But adding a new method has to include a systems approach covering all aspects of adding the method – from policy change, to training to IEC, ensuring commodity supply, counseling, monitoring and evaluation etc. so the method has to be fully integrated into the entire system, both in the public and private sectors to see maximum impact. As for completely new methods being developed or recently developed- these were developed based on a felt need by clients because existing methods all have pros and cons in the perception of the individual user and the current choice of methods may not cover everyone’s needs. so we, in USAID, and other agencies are constantly studying women’s and men’s needs, perceptions, behaviors and program strenghts and weaknesses to ensure the maximum possible choice for individuals around the world. For example, the 12 month hormonal ring, currently under development by the Population Council,will be the first of its kind – a woman controlled longer acting reversible hormonal method. Preliminary information shows us it has the potential to be highly acceptable in some sections of a population and will be a viable choice for many women around the world. Similarly, the fertility awarness based methods, the Standard Days Method (SDM), the Lactational Amenorrhea Method (LAM)and the TwoDay method (TDM), are scientifically tested, highly effective methods that are easy to provide through multi-method FP/RH programs and have increased access for men and women who are interested in fertility awareness based methods. Research in several countries has already shown that clients completely new to family planning are accessing services to use these methods and thereby increasing CPR as mentioned above when new methods are added to a program. More information on these methods are available at the website irh.org. Increasing method choice thereby decreases unmet need,as briefly described above, by addressing the needs of clients who are either not using a method currently or discontinued other methods for various reasons. Quality of care is a related issue. Every method should be provided as part of a package of options so that clients can make informed choices. Optimal counseling, awareness raising, access to the commodities at an affordable cost, etc., are all aspects of quality of care (Please see the Bruce-Jain framework and many other similar documents for a complete discussion of quality of care). Adding new methods to the mix directly affects quality of care by increasing choice (as long as they are actually offered!!) Also, every time a new method is added to a program, it should involve new training of personnel, an examination of existing policies and other systems, etc. all of which may benefit other services including the improved provision of other methods. For example, research has shown that adding the SDM (see above) actually has improved condom counseling as condoms are offered as an option to manage the fertile period in many programs.

Jann Anguish: Are these new, innovative contraceptives being developed mostly for men to use or for women? Are they drugs or chemicals or some other form of contraception? Mihira Karra: The hormonal methods being developed for men ( avery complex issue) are further away from FDA approval and the market than new hormonal methods for women. The new contraceptives that are in the most advanced stages of development currently are the SILCS diaphragm (developed by PATH), a novel one size fits most barrier method for use by women, and a 12 month hormonal ring (developed by the Population Council) which is a unique woman-controlled longer acting method. Both these products are completeing final stages of clinical testing and should be going through FDA approval processes relatively soon. Having said that, there are a couple of new methods, the Standard Days Method (SDM) and the TwoDay Method (TDM)that are truly “couple” methods. These are modern, highly effctive, scientifically validated fertiltiy awareness based methods developed by Georgetown University’s Institute for Reproductive health. Their basic premise is identifying a woman’s fertile period in an easy and effective manner (without any chemicals or test kits) and then allowing the couple to choose to either abstain or use a barrier method during the fertile period to prevent a pregnancy. More information on thse can be obtained at irh.org. These methods are currently being programmed around the world through public and private sector family planning and other health programs. Judy M. Manning: The new methods being developed with USAID support focus on use by women, with the aim of increasing acceptability, affordability, and ease of provision and use. There are several methods nearing introduction status, including the NES-EE vaginal ring (a one-year hormonal method), Depo SQ in Uniject (an easier to provide version of the existing hormonal injection), and the SILCS diaphragm (which does not have to be fitted by a clinician, and may provide additional protection against STIs and RTIs, in addition to pregnancy). USAID is supporting the development of other types of multipurpose prevention technologies that would combine active compounds, hormones, barriers, etc in order to provide protection against pregnancy, STIs (including HIV) and RTIs in one single method.

Dr.S,Mokkapati: Asian Contries like China and Korea are best equipped in modern technologies of materials and needs to be considered for research and development of contraceptives Karin Ringheim: There is considerable contraceptive research underway in Asian countries. Korea was a setting for much early contraceptive research. China has an active contraceptive research program for hormonal and nonhormonal methods for men as well as non-surgical methods for vasecectomy (vas occlusion). The Sino Implant for women profiled in our recent PRB policy brief was developed in China. Research supported by the National Institutes of Health and WHO is underway in a number of Asian countries, including Indonesia. It is important that clinical trials are conducted in different parts of the world both because of cultural differences that may affect acceptability as well as to uncover potential biological differences. For example, in a WHO-supported clinical trial of the male hormone, testosterone undecanoate, it was found that sperm suppression was greater among Asian men than among non-Asian men.

Gary Merritt: The PRB notice doesn’t suggest what ‘new methods’ are to be discussed but these might include follicle-stimulating hormone for males and hCG for females – neither exactly new (eg, USAID funded ‘immunologic’ approaches thru ICMR in India in the mid-’80’s) but perhaps now with innovations making them more feasible? Perhaps new approaches to tubal occlusion? Variations on oral contraceptives? Could discussants order comments on ‘new methods’ by notional program cost-effectiveness – especially for highest-fertility settings like Africa and the ‘Middle East’? Karin Ringheim: As you suggest, research on some of these novel contraceptive approaches has been underway for 20 years, but new discoveries are being made. CONRAD, a contraceptive research program funded by the U.S. government and other donors, is presently researching seven different compounds for disrupting sperm function in men, and it has a Phase IIb (contraceptive efficacy) clinical trial of TU/NET-EN (testosterone undecanoate/norethisertione enanthate) involving 400 couples in 7 countries. The non-hormonal approaches CONRAD and others are investigating are still at an early stage of development. Phase I and II clinical trials of the HCG vaccine have been conducted in humans, and pharmaceutical companies are developing contraceptive vaccines as an alternative to castration for pets, zoos and farm animals. Although the pharmaceutical companies seem less interested in human applications, this work may ultimately help advance contraceptive vaccines for humans. In terms of program cost-effectiveness, perhaps the greatest savings to clients can be realized through increasing access to non-clinical methods, e.g., delivery of injectables by community health workers, which is proving popular in several countries. Long-acting methods such as implants and IUDs are more cost-effective in terms of cost per duration of pregnancy prevention. Given that the great majority of the population of sub-Saharan Africa live in rural areas, a method lasting for a number of years can be considered a big advantage by women who want to delay the next birth by several years or stop having children. Probably the most important thing is increasing access to a range of methods that can meet the diversity of needs of women and men in varying circumstances. Judy M. Manning: The new contraceptive methods to be discussed are those developed specifically for use in resource-poor settings with high fertility rates, which is USAID’s mandate. Criteria include high effectiveness, high acceptability, low cost, and ease of service delivery and use by women. New USAID-supported products to be discussed include Depo SQ in Uniject, the NES-EE one-year vaginal ring, and the SILCS diaphragm.

Adriana Smith: Among the various ideas being developed in male contraceptives (methods other than condoms and vasectomies) which are the most effective in terms of protection and user-acceptance? Which will more likely be on the market first and/or available in international markets? Karin Ringheim: The hormonal methods for men currently in clinical trials are highly effective in suppressing sperm (the method of action)in most men. The acceptability among couples enrolled in clinical trials has been high, particularly among couples who have experienced unacceptable side effects with female methods or who dislike the condom and are not ready for either male or female sterilization. A survey conducted among 9,000 men by the pharmaceutical company Schering found that the majority (55 percent)of men were interested in new methods to control male fertility,and 40 percent of the American men who responded said they would be willing to receive regular injections or use an implant. These methods are not likely to become available in the next 5 years however. Judy M. Manning: USAID is not supporting the development of male hormonal contraceptives given our focus on low-cost methods appropriate for women in low resource settings. However, WHO is currently conducting a Phase II contraceptive effectiveness trial of an injectable hormonal contraceptive for men, and the NICHD (a branch of the NIH) has several activities underway to foster development of a male contraceptive. Suggest you check the websites of those two organizations if you would like further information on their respective activities in this area.

Betty Walakira: I work in Sub-Saharan Africa where there is a very unmet need for contraception and where attitudes of the population have a great role in limiting contraceptive use. One of the major emerging issues is side effects of the methods that we promote and also lack of male participation. For example the IUD causes heavy bleeding and can therefore raise questions as to whether the woman did not have induced abortion. Men seem not to support their women in taking on contraceptive methods while the women complain of side effects. Another issue is with the health workers. The health centres are grossly understaffed such that issues of Family planning are considered not to be of priority. As such a woman may report to a unit looking for contraception only to be told to come back another day or even go to another unit. Now these women are resource constrained and really do not need referral if the methods are there. I keep talking about taking advantage of the opportunity. To me contraception is critical for reduction of poverty, improving quality of lives of the population, reducing chils and maternal mortality and should be key in any health facility. My questions: Are these new contraceptives going to be easy to dispense, not requiring the skills of health workers especially in a country like Uganda where there is high shortage of health proffessionals. Are there other methods of contraceptio proposed for men. Not the condom or vasectomy but others that they can use to prevent them from making women pregnant? Thirdly, in 2009, Uganda reported below 20% of health centres that had no stock out of the injectable. What strategies will be employed with these new methods to ensure that they are in all health units and are therefore accessible to the people who need them? Mihira Karra: Hi Betty, you have touched on all the major issues that we, at USAID, and other organizations consider important and are working on. To touch upon, firstly, my favorite topic – male involvement. For the last 20 years i have been advocating for working with men and have also said several times that one of the mistakes (in hind sight) that the world has made in FP/RH is not involving me from the beginning!! We would have been further ahead today I feel. Given that, a lot of headway has been made in the last decade with many successful pilots that have worked with men and found very positive results for women’s health and FP use. please see the WHO compilation of male involvement programs and programs addressing gender issues (Gary barker et. al.). it has now been finally recognized that addressing gender issues is critical for longer term success of FP/RH and other ehalth programs. It is also a misperception that men are opposed to contraception (even in sub-Saharan Africa). the amjorituy, in fact, want smaller family sizes (please see DHS surveys from multiple countries- you will find very few outliers). The problem is lack of communication among partners leading to misperceptions. All the other factors aer systemic issues that you have mentioned – such as quality of care, provider workloads. etc. Operations and program research have identified many best practices to address many of these issues. a big problem is getting successful interventions scaled up in a consistent and systematic manner. Also, sometimes one good intervention can have multiple effects on other systems issues if implemented well. For example, adding the Standard days Method (irh.org)has not only improved method choice and added a method with no side effects, but has also proven to improve couple communication, increase male involvement, improve condom use and provider counseling skills. the caveat of course, is proper introduction through the entire system. new methods such as the SDM and TDM do decrease the need for commodities and we are in fact looking at new approaches to directly reahc the consumer with these methods without having to go theough the health system. The Institute for reproductive health can provide more information. As for the other new methods, they all address specfic gaps identified in teh field. The new 12 month hormonal ring is the first woman controlled long acting hormonal method. Al hormonal methods and methods such as the IUD will have side effects. Some of the reasons women discontinue these methods is due to inadequate counseling and advice on how to deal with the side effects and lack of choice. At USAID we have developed a minimum list of best practices, tools etc. that have a strong evidence base and that should be part of programs and have the potential for impact. Please e-mail me or nandita Thatte to get this draft list. My e-mail is mkarra@usaid.gov and Nandita, is our Utilization Advisor, here at GH/PRH/RTU USAID/Washington and her e-mail is nthatte@usaid.gov. We continue to conduct program research across the world and provide technical assistance through all of our USAID and partner programs to assist governements and the private sector to increase access to high quality services, not only through the health sector, but also by integrating FP information and services through other sectors to increase reach. Karin Ringheim: We agree that meeting unmet need for contraception is vital to poverty reduction, reaching the Millennium Development Goals for reducing child and maternal mortality, and improving the lives of women and their families. In Uganda alone, it has been estimated (as reported in the PRB publication Family Planning Saves Lives) that meeting the unmet need for contraception between 2005 and 2015 would prevent 4.6 million unintended pregnancies, avert 1.2 million abortions, 800,000 deaths to children under age 5 and nearly 17,000 maternal deaths. You raise some critical issues, including the implications of the health worker shortage in Africa for the broadening of access to family planning and reproductive health. One solution is greater community-based distribution of injectables and pills, and access to methods through pharmacies. The new Depo Sub Q is easier to administer and the packaging in Uniject will assure that needles are not re-used. Another response to health worker shortage is to expand use of long-acting methods. While most still require a visit to a health clinic, a woman needs only to visit once every couple of years for an implant. However, as you noted, stockoouts of these methods are common and highly unfair to the women who have traveled great distances or stood in line only to be told that the method of their choice is not available. All countries need an effective logistical system to assure that supplies increase as demand for contraception grows and that a full method mix reaches all parts of the country. As for new methods for men, the methods under development that are described in answers to other questions here are not going to be available in the near term.

Richard Cincotta: The regions where fertility remains high (west, central & eastern Africa, & parts of central to western Asia) are those in which women’s status is low and the gender gap in education is largest. Is there anything about the new lines of contraceptive research that would specifically address women’s problems in these regions in terms of access, affordability and choice of contraception. Mihira Karra: Hi Rich, In fact, an improtant focus of our programmatic and social science research agenda, here at USAID, is gender. We have had some success in the last decade in improving women’s lives by working with men and w